Safety and Effectiveness of Candesartan and Candesartan/HCT Fixed Dose Combination in Patients with Hypertension

ABSTRACT: to assess the safety
and effectiveness of candesartan and candesartan/HCT fxed-dose combination (FDC)
in patients with hypertension in daily clinical practice. Methods: an open
observational study with a 12-week period of treatment. Candesartan tablets of
4 mg, 8 mg, or 16 mg, or candesartan/HCT FDC tablets (16/12.5 mg) were
prescribed to adult hypertensive subjects, both treatment-naïve patients and
previously treated but uncontrolled patients, depending on the physicians’
discretion based on his/her judgment on the clinical condition. Results: from a
total of 112 treatment-naïve patients and 381 previously treated patients eligible
for safety analysis, there were only 3 patients with adverse events, and 2 of
which were considered possibly related to candesartan (0.41%) and there were no
serious adverse events. Both patients were previously treated patients, one
patient experienced nausea and the other patient experienced paresthesia.
Candesartan and candesartan/HCT were effective in lowering systolic blood
pressure (SBP) and diastolic blood pressure (DBP) from baseline at weeks 4, 8,
and 12, in both groups, with 26-27 mm Hg decreases in SBP at week 12 and a
trend toward a larger reduction in treatment-naïve patients than in previously
treated patients, although not statistically signifcant. However, in terms of
patients achieving a BP of <140/90 mm Hg between groups were signifcantly
superior in treatment-naïve patients than in previously treated patients at
week 8 (56% vs 40%; p = 0.003) and week 12 (69% vs 53%; p=0.004). Candesartan
and candesartan/HCT were also effective for patients with long-standing (>4
years) uncontrolled hypertension with previous antihypertensive therapy, which
was most commonly calcium channel blockers (became controlled in >50% of all
uncontrolled patients). Conclusion: results of this open observational study
showed that candesartan and candesartan/HCT were well tolerated and effective
in both treatment-naïve patients and uncontrolled hypertensive patients with
previous antihypertensive treatment.